Global CMC Requirements - Quality data for marketing authorisations outside the ICH region
- Quality data for the dossier - the formats
- Pharmaceutical documentation for Latin America, Russia and Asia
- Country-specific requirements - import testing
- Global stability programmes
- CMC lifecycle management
This seminar will focus on the CMC
requirements outside the ICH region.
Which data and which formats have
to be provided for a marketing
authorisation?
Two CMC experts will give you a detailed
overview on the general requirements
and pass on their in-depth knowledge of
the Latin American, Russian and Asian
markets.
After attending the seminar you will have
a good understanding on your CMC duties
in the various regions and will have new
input on how to set up global stability
programmes.
Termin
| Datum: | 01.07.2015 |
| Ort: | NH Frankfurt City Vilbeler Straße 2 -60313 Frankfurt |
| Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar addresses the needs of
co-workers in the pharmaceutical
industry. This course will particularly
benefit those dealing with international
CMC topics, such as
- CMC managers
- Regulatory affairs managers
- Managers of the
quality assurance department.
Kontaktinformationen
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